The Crystal M1 Filling Station has been developed to meet small scale pharmaceutical filling. Being manually activated, the filling capacity depends on operator capabilities, with batch size ranging from a few up to 1,500 vials on a single shift basis.
Fully compliant with cGMP requirements, the Laboratory Crystal M1 Filling Station is able to process all sizes of ready-to-fill Crystal Closed Vials.
The complete system is intended for operation in ISO5 conditions, type of containment according to specific product requirements.
The Crystal M1 Filling Station can be installed in following types of containment with various features:
Bio Safety Cabinet (BSC)
Existing Isolator.
Applications
Aseptic filling of liquid parenterals, including Autologous and allogeneic cell therapy, gene therapy.
Intermediate products for cell and gene therapy.
Immunotherapies.
Hospital pharmacy preparations.
Individualized or small batch production.
Specifications
Output (2ml vials) Manual operations, up to 1,500 vials per shift
Filling volume 0.1 ml to 50 ml.
Filling accuracy Typically, 1% (over 1 ml, for water-like viscosity product).
Additional Prep Fees May Apply
